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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
| US Department of Veterans Affairs | FED |
| The Defense and Veterans Brain Injury Center | FED |
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The purpose of this study is to evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PoNS CN-NINM | Experimental | Active CN-NINM PoNS - Active cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy |
|
| Sham PoNS CN-NINM | Sham Comparator | Sham CN-NINM PoNS - Sham cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active CN-NINM PoNS | Device | Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sensory Organization Test (SOT) | Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI) | 12 weeks | |
| Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI) | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
History of traumatic brain injury (TBI) of any severity other than mild TBI
Presence of active substance abuse condition
Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
Orthostatic hypotension as defined by:
An implanted medical device
Pregnancy
Oral infection
Known transmissible disease (HIV, hepatitis, influenza, TB)
Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
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| Name | Affiliation | Role |
|---|---|---|
| David X Cifu, MD | VA Department of Physical Medicine and Rehabilitation | Principal Investigator |
| William C Walker, MD | Virginia Commonwealth University (VCU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | United States | ||
| Virginia Commonwealth University |
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|
| Sham CN-NINM PoNS | Device | Delivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours. |
|
| Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ) |
| 12 weeks |
| Change in quality of life measured using Short Form 36 (SF-36) | 12 weeks |
| Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C) | 12 weeks |
| Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI) | DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner. | 12 weeks |
| Change in neuroimaging using functional magnetic resonance imaging (fMRI) | For fMRI, a repeated single-shot echo-planar imaging will be acquired | 12 weeks |
| Richmond |
| Virginia |
| 23298-3038 |
| United States |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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